510(k) · Cleared

Recalled · Class II · 2023

Actim Prom

K123986510(k) TraditionalCleared Jan 9, 2014379-day reviewClass I21 CFR 862.1550Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alere Scarborough, Inc. · OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Cleared on Jan 9, 2014 as substantially equivalent to K061886 (Medix Biochemica, 2007) after a 379-day review. Its family tree reaches back 2 generations to 2004. It has been recalled once.

Decided: Jan 9, 2014
Review: 379 days
Class: Class I
Product code: OAM
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K030849 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK030849 Amnisure Fetal Membranes Rupture Test Model FMRT1N-Dia, Inc. · 2004 · Recalled
1 generation backK061886 Actim Prom and ControlsMedix Biochemica · 2007
This deviceK123986 Actim PromAlere Scarborough, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K030849	Amnisure Fetal Membranes Rupture Test Model FMRT1	N-Dia, Inc.	2004	1
−1	K061886	Actim Prom and Controls	Medix Biochemica	2007	—
0 (this device)	K123986	Actim Prom	Alere Scarborough, Inc.	2014	—

FIG. 1 — Lineage of K123986, 2004–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K061886	Actim Prom and Controls Summary page 1 …Urinary pH (non-quantitative) Test System (per 21 CFR 862.1550) CLASSIFICATION Class I PRODUCT CODE CAM PANEL Clinical Chemistry PREDICATE DEVICE Actim PROM (510(k) K061886) Pagel1of 4 DEVICE DESC…	Medix Biochemica	2007	—

Also cleared against K061886: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 23, 2023	Class II	Z-1592-2024	Under Investigation by firm	Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K061886.

How does its category compare?

All OAM devices

OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · OAM

1in 2014

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OAM

Too few OAM 510(k)s in any year since 2007 to give a median.

Recalls per year · OAM

No recall names OAM since 2007.

Adverse event reports per year · OAM

3in 2021

2007high 3 (2020) · low 0 (2007)2025

MAUDE reports naming product code OAM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	1
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	3
2021	0	—	3
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Actim PROM test is a visually interpreted, qualitative immunoassay rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. The Actim PROM test detects IGFBP-1, a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a vaginal sample. The test is intended for prescription use in point of care and clinical laboratory settings to help diagnose the rupture of fetal membranes (ROM) in pregnant women > 29 weeks gestation who present with signs, symptoms or complaints suggestive of ROM.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123986 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123986: Actim Prom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123986

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026